Eric Goslau, Transverse Medical - Studio Interview | LSI USA '24

Eric Goslau  0:00  
CEO, CEO with transverse medical. Transverse medical, we're working on point guard, which is a stroke prevention device for use during transcatheter aortic valve replacements. Got our first gen device basically ready in the design freeze, probably close to around 2016 following all the funding in 2013 went into first in human in Europe, which was good, and then ended up pausing that that study after about four patients, and modified the device into what we have today, which is what we call point guard 2.0 so that was right around the preamble of the pandemic. We anticipated that we probably be able to raise at least a series B right around that time frame, to move the device from that first experience. Fortunately, we were able to forge through that and survive the pandemic. Kind of the fast forward where we're at today. We just finished up a series b1, this past August, utilizing capital from our inside investors and a little bit of non diluted funding that came through as well. And so that kind of just recalibrated the whole system. Was able to get our device 2.0 generation into design freeze. And now we're moving forward towards a feasibility study that will likely take place outside the US in Australia, and then we're using that information to work with FDA to apply for an ID approval for pivotal study in the US. A little bit about point guard. Our device covers the entire Great arch, so it's a full brain protection solution. So, so that's what the second gen device really was. Kind of breakthrough. With that asymmetric design, it essentially became longer and wider so we could cover more of the aortic arch. We also added in what we call the aortic cantilever spring, so it's a unique flexibility mechanism to push pressure up into the aortic arch and create a perimeter seal so that it stabilizes throughout the procedure and what we refer to as cardiac output. So every heartbeat essentially right the the aortic arch is semi, you know, moving and contracting, right? So the point guard, or an embolic protection device in general, has to stabilize in place and be able to react with that cardiac output. And so that's what the aortic cantilever spring does. The other nice feature too on the second gen device is what we call auto responsive positioning. So we use a unique combination of flat nitinol and concentric nitinol driveshaft. So you have flat properties with circular properties, essentially. And so when it's deployed out of the delivery system itself, rights into the anatomy, it's one of the features when our operators were testing the first gen to the second gen driven device, and we were trying to perfect that auto responsive positioning. That's one of the comments that came back, is that they really liked that a lot, because all they had to do was find the landing zone in the descent, in the ascending aorta, position the point guard where they wanted to do that, or pull back and then pull it back, and it just positions into the aortic arch and conforms to that anatomy for each of the patients, the standard care right now is either unprotected, meaning no protection for these TAVR patients, right? So that's our primary focus. Procedure is transcatheter aortic valve replacements. In that procedure, there's documented average major stroke around 5% some clinical trials have shown that major stroke as high as 9% there's only one approved device in the market, and that's by Boston Scientific and that device is called the Sentinel, and so that's a partial protection solution. So those are your options in the market right now. Either you have no protection or you have partial protection, and that leaves a big door for addressing the unmet need with full brain protection to come in, because the embolic protection company that hits that and does it right with a simple solution like the point guard, that's going to be a game changer. For sure, every patient is at risk for stroke during a transcatheter valve replacement. We can't predict when stroke is going to happen, right? And then stroke rates above 1% are unacceptable. So the market potential is every TAVR procedure, or every patient that's going in to have a TAVR done should have an embolic protection device. I like to use the analogy of it's like a seatbelt you get in your car. You don't know when you're going to get an accident, but you put on your seatbelt, right? Because we know statistically, those save lives, right? The market potential in TAVR. So is essentially, you know, when you look at some of the the pricing out there from the competitive device, the only one that's available market potential is roughly around, globally, it's about a billion dollar market. But there's other there's other procedures like I mentioned. You know, there's applications in mitral valve, potentially into tricuspid and then we're looking at developing embolic protection for other markets too, not just in the cardiovascular space within structural heart, but looking at thoracic grafts, or like tvars, there's documented stroke rates that are in the double digits in that market. Our Aggie team at transverse has been looking at some modalities to basically go in and address that. Two so when they put in the T bar graphs, they have protection. So the feasibility study is going to take place sometime this year. When I say sometime, it's like mid year, right? So we're targeting somewhere around August, September time frame, and that'll be a small study. Again, it's just feasibility to look for safety and performance of the next generation device. But in parallel, we're working with FDA, and we'll be scheduling some, you know, pre submission meetings with the FDA to take some of the innovative ways that we're going to look at, to study, to show a patient benefit. We're looking to to work with FDA to do that so that we can move forward quickly and rapidly into that pivotal study. And that pivotal study will likely start maybe towards the end of this year, possibly towards maybe the beginning of next year. So that's kind of our time frame. We're We're in a tight, you know, tight space, or a tight timeline right now to try to hit some key milestones, but it's all within the next 16 to 18 months, if we can move in that direction and do it promptly and quickly, have a successful clinical trial, both with the nice operator, ease of use and the simplicity of the point guard. Our goal is that we'd become standard of care for embolic protection during at least, at a minimum TAVR procedures. Our vision then going even further is that we start to expand that into other important procedures that have high rates of stroke. I mean, everybody always says 1% is unacceptable, right? But even if you have lower percentages, or under 1% and you know that you have some form of way to protect a patient's brain, and it's simple and easy to use, it's going to end up being put into a lot of other procedures, right? So that's kind of the vision. And you know, outside of commercializing the device and taking that standard path of doing that. If there's other ways that we can bring in other technologies to put into the bag as well, we certainly could do that as a standalone company and offer more products. We're actually considering things like that. But essentially too, we're interested in entertaining opportunities too with strategics. If that comes about, the likely acquirers in this space are the TAVR companies, right? It makes good sense, right? And that's the focus. Strokes can't be predicted, and they happen in all great patients. So we want to be able to provide involved protection or the point guard to essentially every valve company out there. But it just makes good sense that at least you know, if some valve company's looking for a market advantage or a competitive advantage, they potentially could be acquired for, for transfers. So.